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A Dose-ranging Study of Orvepitant in Patients With Chronic Refractory Cough

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02993822
Recruitment Status : Completed
First Posted : December 15, 2016
Last Update Posted : March 13, 2020
Sponsor:
Information provided by (Responsible Party):
Nerre Therapeutics Ltd.

Study Description
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Brief Summary:
The purpose of this study is to determine the effectiveness of three doses of orvepitant, taken once a day, in the treatment of chronic refractory cough.

Condition or disease Intervention/treatment Phase
Chronic Refractory Cough Drug: Orvepitant Maleate Drug: Placebo Phase 2

Detailed Description:

A multi-center, double-blind, randomized, parallel group, placebo-controlled dose range study in subjects with chronic refractory cough (CRC).

Doses of orvepitant (10 mg/day, 20 mg/day and 30 mg/day) and placebo will be investigated in four parallel groups.

Each group will compromise of approximately 61 subjects, randomized 1:1:1:1 (approximately 244 subjects in total).

All subjects will enter a three-week screening period to determine eligibility. Eligible subjects will be randomized at the Baseline/Day 1 visit and enter a 12-week double-blind dosing period. During this period there will be four visits at Weeks 2, 4, 8 and 12. There will be a final safety follow-up visit at Week 14.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 315 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo Controlled Study of the Efficacy and Safety of Three Doses of Orvepitant in Subjects With Chronic Refractory Cough
Actual Study Start Date : May 10, 2017
Actual Primary Completion Date : February 11, 2019
Actual Study Completion Date : February 25, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arms and Interventions
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Arm Intervention/treatment
Experimental: Orvepitant 10mg
Orvepitant 10mg tablet, once daily for 12 weeks
 Drug: Orvepitant Maleate
Tablet, once daily, oral
Experimental: Orvepitant 20mg
Orvepitant 20mg tablet, once daily for 12 weeks
 Drug: Orvepitant Maleate
Tablet, once daily, oral
Experimental: Orvepitant 30mg
Orvepitant 30mg tablet, once daily for 12 weeks
 Drug: Orvepitant Maleate
Tablet, once daily, oral
Placebo Comparator: Placebo
Placebo to match tablet, once daily for 12 weeks
 Drug: Placebo
Tablet, once daily, oral


Outcome Measures
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Primary Outcome Measures :
  1. Awake objective cough frequency [ Time Frame: Week 12 ]
    Objective cough frequency measured by ambulatory cough monitoring device


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Male and female subjects ≥18 years of age.
  • Diagnosis of CRC or unexplained cough for at least 1 year (see ACCP/BTS guidelines attached).
  • A awake average cough frequency of ≥10 coughs/ hour, as assessed using an ACM during the screening period.

Key Exclusion Criteria:

  • Subjects with respiratory tract infection (<4 weeks prior to study start)
  • Current smokers or ex-smokers with <6 months' abstinence or cumulative history of >10 pack years
  • Treatment with Angiotensin Converting Enzyme (ACE) inhibitors within 3 months of screening
  • FEV1 <80% predicted, measured at screening using spirometry
  • History of cystic fibrosis, idiopathic pulmonary fibrosis, clinically significant bronchiectasis, moderate to severe asthma, chronic obstructive pulmonary disease (COPD)
  • Any clinically significant abnormal laboratory test result(s)
  • Inability to comply with the use of prohibited and allowed medications as described in the protocol.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02993822


Locations
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Sponsors and Collaborators
Nerre Therapeutics Ltd.
More Information
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Responsible Party: Nerre Therapeutics Ltd.
ClinicalTrials.gov Identifier: NCT02993822    
Other Study ID Numbers: VOLCANO-2
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Maleic acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action